Device class
Class II
Regulation 882.1400
Total clearances
16
2020-05-18 → 2026-06-24
Definition
What is Automatic Event Detection Software For Full-Montage Electroencephalograph
Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user
Classification details
Medical specialty
Neurology
Regulation number
882.1400
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 95957 |
CPT
|
— |
High
|
Digital analysis and interpretation of electroencephalogram with automatic spike and seizure event detection |
| 95819 |
CPT
|
— |
Medium
|
Electroencephalogram initial service; automatic seizure detection software included in comprehensive EEG analysis |
Pulse
Most recent 510(k) clearances